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Also known as BMS-833923 (XL139)
BMS-833923 · 5 trials · 9 indications
* NCI - National Cancer Institute * CTCAE - Common Terminology Criteria for Adverse Events * MTD - Maximum tolerated dose * DLT - Dose limiting toxicity
MTD - maximum tolerated dose
Use NCI CTCAE to monitor safety assessments including physical findings, laboratory tests, and radiographic assessments to establish the maximum tolerated dose and recommended Phase 2 dose range and schedule of BMS-833923
| Arm | Type | Description |
|---|---|---|
| Arm 1: BMS-833923 (XL139) | EXPERIMENTAL | - |
| All Subjects | EXPERIMENTAL | - |
| Arm 1 | EXPERIMENTAL | BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter) |
| Arm 2 | ACTIVE_COMPARATOR | BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg) |
| Arm 3 | ACTIVE_COMPARATOR | BMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose) |
| BMS-833923 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-833923 (XL139) | DRUG | Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria |
| BMS-833923 | DRUG | Capsule, Oral, starting dose 30 mg, once daily, continuous |
| Carboplatin | DRUG | Vial, Intravenous (IV), dose to yield 5 mg/mL - min, once every 21 days, 1 day per cycle up to 4 cycles |
| Etoposide | DRUG | Vial, Intravenous (IV), 100 mg/m²/dose, days 1, 2, \& 3 of each 21 day cycle, 3 days per cycle for up to 4 cycles |
| Cisplatin | DRUG | Vial, intravenous (IV), 80 mg/m² IV, Once every 21 days, 1 day per cycle until discontinuation from study |
| Capecitabine | DRUG | Tablets, Oral, 1000 mg/m², twice a day (BID), 14 days per cycle, until discontinuation from study |
| Lenalidomide | DRUG | Capsule, Oral, Once daily, 6 months |
| Dexamethasone | DRUG | Capsule, Oral, Once a week, 6 months |
| Bortezomib | DRUG | Powder, IV, On days 1, 4, 8, 11, 6 months |
Inclusion Criteria: * Subjects with advanced or metastatic solid tumors refractory to, or relapsed from, standard therapies or for which there is no known effective treatment * Men and woman, 20 years of age and above Exclusion Criteria: * Subjects with symptomatic brain metastasis or active brai...
BMS-833923 is an investigational small molecule studied in adults with advanced solid tumors and blood cancers. Trials have enrolled patients with small cell lung carcinoma, gastric and gastroesophageal or esophageal adenocarcinomas, multiple myeloma, and other advanced cancers, including a study conducted in Japan.
BMS-833923 targets SMO, short for Smoothened, a component of the Hedgehog signaling pathway. It acts as an antagonist, meaning it blocks SMO activity. The Hedgehog pathway is associated with several tumor types, which is the rationale for studying this compound in advanced cancers.
BMS-833923 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The compound is also referred to as BMS-833923 (XL139), reflecting an alternate designation used in study titles and publications.
BMS-833923 is in Phase 1 clinical development and is investigational. It has not been approved by the FDA for any indication. All four recorded studies of the drug were Phase 1 trials, and each of those trials is now completed, with no active trials currently listed.
BMS-833923 has been evaluated in four completed Phase 1 trials: NCT01413906 in solid tumors in Japan, NCT00927875 with carboplatin and etoposide in extensive-stage small cell lung cancer, NCT00909402 with cisplatin and capecitabine in gastric and esophageal adenocarcinomas, and NCT00884546 in multiple myeloma.
Yes. BMS-833923 is also known as XL139, and the two names refer to the same investigational compound. Study titles list it as BMS-833923 (XL139), so readers searching either name are looking at the same SMO antagonist developed by Bristol-Myers Squibb.